Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
GRANULE, FOR SUSPENSION
**Dosage and Administration** Soficlor is administered orally. To reconstitute: Shake to loosen powder. Add water and shake vigorously to disperse powder. Add water to the 60 ml mark and shake well. _Adults:_ The usual adult dosage is 250 mg every 8 hours. For bronchitis and pneumonia, the dosage is 250 mg administered 3 times daily. A dosage of 250 mg administered 3 times daily for 10 days is recommended for sinusitis. For more severe infections (such as pneumonia) or those caused by susceptible organisms, doses may be doubled. Doses of 4g/day have been administered safely to normal subjects for 28 days, but the total daily dosage should not exceed this amount. For the treatment of acute gonococcal urethritis in males and females, a single dose of 3g combined with probenecid 1g is given. _Children:_ The usual daily recommended dosage for children is 20mg/kg/day in divided doses every 8 hours. For bronchitis and pneumonia, the dosage is 20mg/kg/day in divided doses administered 3 times daily. In more serious infections, otitis media, and infections caused by less susceptible organisms, 40mg/kg/day in divided doses are recommended, with a maximum dosage of 1g/day. For Soficlor Oral Suspension 125mg/5ml Child's weight (kg)20mg/kg/day40mg/kg/day92.5 ml t.i.d.5 ml t.i.d.185 ml t.i.d.10 ml t.i.d. B.I.D. Treatment option: for treatment of Otitis Media and pharyngitis, the total daily dosage may be divided and administered every 12 hours. Soficlor may be administered in the presence of impaired renal function. Under such a condition, the dosage is usually unchanged. In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of Soficlor should be administered for at least 10 days.
ORAL
Medical Information
**Indications** Soficlor Oral Suspension is indicated in the treatment of the following infections when caused by susceptible strains of the microorganisms: Otitis media: caused by _S. pneumoniae, H. Influenzae_, staphylococci, _S. pyogenes_(group A β-hemolytic streptococci), and _M. catarrhalis_. Lower respiratory tract infections: including pneumonia, caused by _S. pneumoniae, H. influenzae, S. pyogenes_ (group A β-hemolytic streptococci), and _M. catarrhalis_. Upper respiratory tract infections: including pharyngitis and tonsillitis, caused by _S. pyogenes_ (group A β-hemolytic streptococci), and _M. catarrhalis_. Note: Penicillin is usually the drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Amoxycillin has been recommended by the American Heart Association as the standard regimen for the prophylaxis of bacterial endocarditis for dental, oral and upper respiratory tract procedures, with penicillin V, a rational and acceptable alternative in the prophylaxis against α-hemolytic streptococcal bacteremia in this setting. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of either rheumatic fever or bacterial endocarditis are not available at present. Urinary tract infections: including pyelonephritis and cystitis caused by _E. coli, P. mirabilis, Klebsiella_ sp. and coagulase-negative staphylococci. Note: Cefaclor has been found to be effective in both acute and chronic urinary tract infections. Skin and skin structures infections: caused by _Staphylococcus aureus_ and _S. pyogenes_ (group A β-hemolytic streptococcus). Appropriate culture and susceptibility studies should be performed to determine the susceptibility of the causative organism to cefaclor.
**Contraindication** Soficlor is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
J01DC04
cefaclor
Manufacturer Information
APEX PHARMA MARKETING PTE. LTD.
XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD
Active Ingredients
Documents
Package Inserts
Proposed PI_Soficlor OS 261219.pdf
Approved: October 12, 2020